Angiex, a developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid cancers, announced that patient dosing has begun for their Phase 1 clinical trial of AGX101, a first-in-class TM4SF1-directed Antibody-Drug Conjugate (ADC). Angiex partnered with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, to support the development, manufacture and supply of clinical trial material for the study.
AGX101 is a TM4SF1-directed ADC that targets two compartments of the tumor, cancer cells and the tumor vasculature. AGX101 has three mechanisms of action: eliminating tumor blood vessels, killing tumor cells capable of invasion and metastasis, and directing the immune system to attack the cancer. Abzena has supported the development of AGX101 with an integrated program that included linker-payload design and synthesis, bioconjugation, process development, and cGMP manufacturing for Angiex’s Phase 1 trial.
Paul Jaminet, co-founder and CEO of Angiex, said: “We are very excited to have dosed our first patient in our first-in-human study of our novel TM4SF1 ADC, AGX101. Throughout the development of AGX101, Abzena has worked closely with us to achieve successful GMP manufacturing and quality control. We could not have reached this milestone without Abzena’s expertise, cooperation, and support. Both companies have extensive expertise in their respective fields and an aligned mission, and we look forward to continuing our partnership to ensure that AGX101 is available to meet the needs of clinical cancer patients. We are delighted that Abzena shares our vision that no one should die of cancer.”
Matt Stober, CEO of Abzena, said: “The Abzena team is incredibly proud to have helped Angiex achieve this significant milestone. Our unique ability to support Angiex with a fully integrated approach allowed us to de-risk and rapidly progress AGX101 into the clinic for patient dosing. We will continue supporting Angiex with our extensive ADC expertise and integrated capabilities to accelerate the development timeline of AGX101, and ultimately get this life-changing treatment to cancer patients faster.”
The Phase 1 study for AGX101 is an open-label, dose-escalation, and expansion study designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of AGX101 monotherapy. The dose escalation portion of the study is designed to assess doses up 10 mg/kg in an all-comers, solid tumor patient population. The dose expansion portion of the study is designed to evaluate treatment at the Recommended Phase 2 Dose in multiple indications.
